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The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Alabama Liver and Digestive Specialist
Montgomery, Alabama, United States
Clopton Clinic
Jonesboro, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Providence Clinical Research
Burbank, California, United States
Southern California Liver Centers
Coronado, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
eStudy Site
Oceanside, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
Medical Associates Reseach Group
San Diego, California, United States
Kaiser Permanente Hepatology Research
San Diego, California, United States
Start Date
March 1, 2011
Primary Completion Date
August 1, 2012
Completion Date
August 1, 2012
Last Updated
May 26, 2014
332
ACTUAL participants
Sofosbuvir
DRUG
RBV
DRUG
PEG
DRUG
Lead Sponsor
Gilead Sciences
NCT05870969
NCT03987503
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04382404